1、A-A-51826 66 = 7777779 0010822 7 A-A-5 182 6 18 FEBRUARY 1987 COMMERCIAL ITEM DESCRIPTION SEPARATOR, SERUM AND PLASMA The General Services Administration has authorized the use of this comercial item description. This comnercial item description covers a disposable serum-plasma Separation device for
2、 separation of serum and plasma from a whole blood sample that is being centrifuged. Salient characteristics: Shall be a disposable polyethylene device that is filed with sealant for use in the separation of serum and plasma from a whole blood sample. The sealant shall be an inert semi-solid mixture
3、 of silicone fluid and silica. Shall be designed for use with standard 13 millimeter (m) and 16 m inside diameter sized blood collecting tubes. Shall be supplied with a package insert that includes the manufacturers reconmended instructions for proper use. Shall be suitable for use in serum-plasma s
4、eparations of whole blood samples by centrifuging involving a minimum relative centrifugal force of 500 g for a 10 minute period. Shall have polyethylene device constructed in the form of a tiered funnel with a projecting nozzle. The upper portion of the funnel shall have step dawn construction that
5、 includes a nominal 3/4 inch top rim diameter, and reduced tier rim diameters (nominal) of 5/8, 1/2 and 3/8 inches. Shall have inside cavity of polyethylene devise filled with the sealant, and a protective covering shall be included on top of the 3/4 inch diameter rim. Shall be designed for separati
6、on of a whole blood sample in a blood collecting tube, in accordance with following: AMsc N/A FSC 6640 DISTRIBVTION STATEMENT A. Approved for public release; distribution is unlimitd. Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-. I A-A-5 182 6 1.
7、 instructions, so that the nozzle penetrates the blood sample, and closure on open end of the tube is provided by the upper portion of the device, Insertion of device into tube, in accordance with manufacturers 2. Centrifuging of bld sqle with device in place releases sealant, through nozzle opening
8、 of the device and into the blood sample, and forms a complete barrier between serum and plasma. 3. After centrifuging the released sealant maintains serum-plasma separation and allows for serum pair-out after removal of the device. Workmanship. The serum-plasma separation device shall be free from
9、defects that affects its appearance or impairs its serviceability. - nit. Package (PG). One package containing one thousand separators, together with manufacturers reccPmiended instructions for use, as Specified, constitutes one unit . puality Assurance Provisions. Responsibility for inspection. Unl
10、ess otherwise specified in the contract or purchase order, the contractor is responsible for the performance of all inspection requirements as specified herein. Except as otherwise specified in the contract or purchase order, the contractor may use his own or any facilities suitable for the performa
11、nce of the inspection requirements specified herein, uness disapproved by the Government. The Government reserves the right to perform any of the inspections set forth in the specification where such inspections are deemed necessary to assure supplies and services confom to prescribed requirements.
12、Records. Records of examinations and tests performed by or for the contractor shall be maintained by the contractor and made available to the Government upon the Governments request, at any time, or from time to time, during the performance of the contract and for a period of three years after deliv
13、ery o the supplies to which such records relate. Inspection. Inspection, as used herein, is defined as both examination (such as visual or: auditory investigation without the use of special laboratory appliances or procedures) and testing (determination by technical means of physical and chemical pr
14、operties) of th item. Tests. Tests shall be conducted in accordance with comnercial practice to determine compliance with specification requirements. Sampling for inspection and tests. Sampling for inspection and tests shall be conducted in accordance with comnercial practice. 2 Provided by IHSNot f
15、or ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-51826 66 m 7777774 0010824 2 m A-A-5 18 2 6 Contractor certification. The contractor shall certify that the product offered meets the salient characteristics of this description and conforms to the producers own drawin
16、gs, specifications, standards, and quality assurance practices. The Govrnment reserves the right to require proof of such confontiance prior to first delivery and thereafter as may be otherwise provided for under the provisions of the contract. Requlatory requirements. Federal Food, Druq and Cosmeti
17、c Act. If the product covered by this document has been determina by the U.S. Food and Drug Administration to be under its jurisdiction, the offeror/contractor shall comply, and be responsible for .compliance by its subcontractors/suppliers, with the requirements of the Federal Food, Drug and Cosmet
18、ic Act, as amended, and regulations promulgated thereunder. comply, and be responsible for compliance by its subcontractors/suppiiers, with the requirements of all other applicable Federal, State, and local statutes, ordinances, and regulations. In addition, the offeror/contractor shall Recovered ma
19、terials. The offeror/contractor is encouraged to use recovered material in accordance with Public Law 94-580 to the maximum extent practical . Preservation, packaqing, packinq, labelinq, and marking. Unless otherwise specified, preservation, packaging, and packing shall be to a degree of protection
20、to preclude damage to containers and/or contents thereof under normal shipping conditions, handling, etc. , involving shipment from the supply source to the receiving activity, plus reshipment from receiving activity, and shall conform to applicable carriers rules and regulations. Intermediate and e
21、xterior package quantities and labeling and marking shall be as specified in the contract and/or order. NcTrE: The following National Stock Number is covered by this document: 6640-01-226-6500 Orderinq data. marking must be specified in the contract and/or order.) (Intermediate/exterior package quan
22、tities , labeling, and MILITARY IWJ3RJ3sTS: Custodians: AW-MD Navy - MS Air Force - 03 Preparing Activity: DD - MJ3 Agent : DLA-DM 3 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-51 82 6 CIVIL AGENCY COORDINATING ACTIVITY: VA-OSS PHS FDA-MPQAS Project No. 6640-1421 Location: NCR Disk #3 4 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-
